Ischemia Clinical Trial
— EDIROfficial title:
Early Discovery of Ischemia After Replantation Surgery of the Extremities (EDIR-study) ; An Open, Prospective, Intervention Study
Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the replanted extremity. Local tissue CO2 and temperature will be monitored continuously postoperatively for the next 10 days. If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators. This will lead to assessment of the replanted extremity and if restricted blood flow is diagnosed, a reoperation will be performed. After reoperation new sensors will be implanted for another ten days if applicable. Sixty patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 500 devices is planned to be used in this clinical study.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients must be in need of extremity replantation surgery - Subject must be = 18 years - Able to give written signed informed consent Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Sensocure AS |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of pack-years | Smoking habit; number of pack-years by participants | 30 days | |
Other | Preoperative ischemia time | Preoperative ischemia time of the amputated limb (minutes) | 12 hours | |
Other | Intravenous fluid | Intravenous fluid given during surgery (ml) | 12 hours | |
Other | Vasoactive drugs | Vasoactive drugs given during surgery (microgram) | 10 hours | |
Other | IscAlert functionality | Number of hours with a well-functioning sensor (giving CO2- and temperature data) | 10 days | |
Other | Physical examination of the reimplanted extremity - capillary filling | Time of capillary filling (seconds) | 10 days | |
Other | Physical examination of the reimplanted extremity - color | Color of reimplanted extremity (Red or Pale) | 10 days | |
Other | Physical examination of the reimplanted extremity - temperature | Temperature of reimplanted extremity (degrees Celsius) | 10 days | |
Primary | Tissue CO2-level | Tissue CO2-level (kPa) during insertion period | 10 days | |
Secondary | Bleeding | Amount of blood from insertion site (ml) | 10 days | |
Secondary | Infection | Infection from insertion site at the discretion of the investigator (yes or no) | 30 days | |
Secondary | Length of stay at hospital | Number of days from end of initial operation to primary hospital discharge + Number of days from transfer from primary hospital to discharge from secondary hospital. | 30 days | |
Secondary | Time to reduced blood flow in replanted extremity | Number of days and hours from primary replant surgery end to obstructed blood flow is diagnosed. | 10 days | |
Secondary | Number of re-operations | Number of reoperations caused by replant necrosis/ischemia in the replanted extremity | 30 days |
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